Published: October 21, 2019
- Compliance System, Training Program, Corrective and Preventive Action (CAPA), and Compliant Management, Investigations.
- The scope of this position encompasses, but is not limited to, management of product Quality functions, Continuous Improvement initiatives, and development, implementation and effective verifications of investigations and corrective and preventive actions (CAPAs and Complaints).
- Will lead and provide technical support during FDA inspections and Notified Body audits and will manage all internal and In-process audit programs for the facility.
- The Senior Quality Systems Manager will actively participate with the QA Staff to provide solutions to Quality problems, and facilitate management in the tracking of Management Review and Quality Performance metrics.
- He/she will serve as a liaison with other divisions and manufacturing facilities on all Quality Systems related matters.
- He /She is responsible for the direct supervision to the personnel, both exempts and non-exempts, with direct responsibilities on the areas described above (Laboratory, Complaint Handling, Compliance and CAPA).
- Strong knowledge of US FDA and International regulations governing the medical device industry (i.e. QSR, GMP, MDR, and ISO standards.
- Extensive experience in CAPA, Failure Investigation and Management Reviews
- Must be bilingual (English/Spanish)
- Must have good communication skills both oral and written
- Strong analytical and problem-solving skills used to judge the quality, timeliness and completeness of our CAPAs.
- Strong training, coaching, and mentoring skills.
- Ability to influence and train others. In this role, candidates need to be able to change the behaviors of others through coaching and mentoring.
- Demonstrated ability to identify root cause of a problem, and creatively problem-solve to gain resolution.
- Excellent technical writing skills.
- Demonstrated ability to interpret technical information.
- Demonstrated ability to understand regulatory requirements.
- Demonstrated ability to apply statistical techniques in problem solving situations.
- Strong managerial skills and ability to manage departmental budgets.
- 8+ years’ experience in Quality field and in an FDA and ISO 13485-regulated environment; or equivalent combination of education and experience
- Bachelor's degree in Science
- Additional Desirable Qualifications Skills and Knowledge: Green Belt Certification required, with demonstrated success leading comprehensive investigations and implementing innovative and effective solutions to complex problems
Black Belt certification